Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

Wyeth is now a wholly owned subsidiary of Pfizer350 enrolled

Overview

This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

350

Conditions

Depression

Interventions

Effexor® (Venlafaxine)DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1). * A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2). * Patients above 18 years of age who meet the eligibility requirements. EXCLUSION CRITERIA: * Patients taking MAOI's within 2 weeks prior to the survey. * Patients known to be suffering from bipolar disorder or schizophrenia. * Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy. * Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.

Outcomes

Primary Outcomes

Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.

Secondary Outcomes

Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.

Data from ClinicalTrials.gov

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